Nivolumab Alone or Plus Relatlimab or Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

About this trial

This is a phase 2 trial assessing the efficacy of nivolumab, alone or in combination with relatlimab or ipilimumab in treating patients with locally-advanced unresectable or metastatic basal cell carcinoma.

Eligibility criteria

Qualifiers

Signed Written Informed Consent

Subjects must have signed and dated an Institutional Review Board (IRB)-approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care.

Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study.

Type of Participant and Target Disease Characteristics

Disqualifiers

Medical Conditions

Pregnant or nursing women

Central nervous system metastases, unless stable for at least 4 weeks and no longer requiring steroid therapy.

Patients with an autoimmune disease or with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications may be permitted to enroll only after discussion with the study P.I.

Trial design

Treatments tested in this trial

  • Nivolumab
  • Ipilimumab
  • Relatlimab

Treatment groups

57 Participants
are divided into 3 treatment groups

Sponsors and collaborators